UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008049 |
|---|---|
| Receipt number | R000009480 |
| Scientific Title | Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat |
| Date of disclosure of the study information | 2012/05/30 |
| Last modified on | 2016/08/25 10:54:30 |
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Basic information
Public title
Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat
Acronym
Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat (E-RIGHT study)
Scientific Title
Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat
Scientific Title:Acronym
Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat (E-RIGHT study)
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the clinical effect of ezetimibe on LDL-cholesterol(LDL-C), other serum lipids and glucose metabolism in hypercholesterolemia patients with impaired glucose tolerance
2. To clarify beneficial patients of ezetimibe treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Comparison of LDL-C level between groups
Key secondary outcomes
Changes and comparison of
each serum lipid level, Apolipo protein level, glucose metabolism level, laboratory test level, atherosclerosis index level, BMI, waist circumference, adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Statin treatment
Rosuvastatin 5mg
Interventions/Control_2
Combination treatment
Rosuvastatin 2.5mg + ezetimibe 10mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) LDL-C level exceeds target LDL-C level(Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007) after at least 4 weeks of rosuvastatin treatment
2) 5.5%<=HbA1c(NGSP)<6.5% or 110mg/dL<=fasting blood glucose<126mg/dL
Key exclusion criteria
1) HbA1c>=6.5%(NGSP)
2) Hypersensitivity to test agents
3) Treating with antihyperlipidemic agents other than rosuvastatin
4) Severe hepatic dysfunction: any one of following
(i)AST>=100IU/L
(ii)ALT>=100IU/L
(iii)Cirrhosis
5) Severe renal dysfunction: serum creatinine>=2.0mg/dL
6) History of acute coronary syndrome(myocardial infarction, angina) and stroke within 3 months
7) Secondary hyperlipidemia, drug induced hyperlipidemia
8) Pregnant, breast-feeding, becoming pregnant
9) Familial hypercholesterolemia
10) Inadequate to this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyuki SHIMIZU |
Organization
Jikei University School of Medicine,Kashiwa Hospital
Division name
Division of Cardiology Department of Internal Medicine
Zip code
Address
163-1, Kashiwashita, Kashiwa city, Chiba
TEL
04-7164-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyuki SHIMIZU |
Organization
Jikei University School of Medicine,Kashiwa Hospital
Division name
Division of Cardiology Department of Internal Medicine
Zip code
Address
163-1, Kashiwashita, Kashiwa city, Chiba
TEL
04-7164-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine,Kashiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kashiwa Heart Clinic
Fujiki Clinic
Takeda Clinic
Nedo Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学付属柏病院(千葉県)
東京慈恵会医科大学附属病院(東京都)
医療法人社団 慈雅会 柏ハートクリニック(千葉県)
医療法人社団 藤木医院(千葉県)
竹田内科医院(千葉県)
根戸クリニック(千葉県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 29 | Day |
Last modified on
| 2016 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009480
